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SafeOp

FDA UDI

Class II (US FDA UDI)

by Alphatec Spine, Inc.

Identity

Trade Name
SafeOp FDA UDI
Generic Name
Neurophysiologic monitoring system FDA UDI
Device Name
SafeOp Head Unit FDA UDI
Model / Reference
AIX1190A FDA UDI
Description
SafeOp Head Unit FDA UDI

Identifiers

Primary DI / UDI-DI
00190376234755 FDA UDI
510(k) Number
K182542 FDA UDI
FDA Product Code
GWF FDA UDI
IKN FDA UDI
ETN FDA UDI
PDQ FDA UDI
GMDN Term
Neurophysiologic monitoring system FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
882.1870 FDA UDI
890.1375 FDA UDI
874.1820 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Neurophysiologic monitoring system

SafeOp by Alphatec Spine, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Neurophysiologic monitoring system.

Cleared under the same submission

K182542 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Alphatec Spine, Inc.

Sources (1)

  • FDA UDI 41e6640a-3f03-4202-a9de-2676de9903b2 35 fields · synced Jun 8, 2026